MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neuropathy (1983)

Event Date 06/01/2015

Event Type  Injury  

Manufacturer Narrative

The pipeline devices will not be returned for analysis as they were implanted in the patients.Based on the reported information, there is no evidence suggesting that the devices were defective.All patients presented with cranial neuropathy before pipeline treatment; the cause of continued neuropathy in the patients after pipeline treatment could not be conclusively determined from the provided information.Brown, b.(2015).Oral presentations 2014 aans annual scientific meeting san francisco, california ¿ april 5¿9, 2014 published online june 1, 2015; doi: 10.3171/2015.6.Jns.Aans2014 abstracts.Journal of neurosurgery, 122(6), a1552.Doi:10.3171/2015.6.Jns.Aans2014 abstracts.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from literature review of patient outcomes after pipeline treatment.The purpose of this article was to compare endovascular flow diversion with microsurgical decompression in restoring function in cranial neuropathy.The medical records of 43 patients with 43 treated aneurysms that fit the criteria were retrospectively reviewed.The patients had presented with cranial neuropathy (2, 3, 4, and 6th cranial nerve) due to cerebral aneurysms and had been treated with the pipeline embolization device.The aneurysms were located the internal carotid artery (ica) (cavernous or distal to cavernous segment).There were 40 females, 3 males, mean age of 64.5years.It was reported that the 30-day morbidity was 14%.It was also reported that the rate of cranial nerve improvement after pipeline was 39.5%, 69.2%, and 81.25% at 3, 6, and 12 months, respectively.

Manufacturer Narrative

Event description - additional information.Initial report - additional information.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received additional information from review of an article by the same authors.The purpose of the article was to determine whether flow diversion with pipeline embolization device (ped) can approximate microsurgical decompression in restoring function after cranial neuropathy following carotid artery aneurysms.The authors reviewed 45 patients with 45 aneurysms in the proximal intracranial internal carotid artery (ica) treated with ped.Of the patients, 42 were female and 3 were male; mean age was 64.7 years.All 45 patients presented with symptoms of cranial neuropathy.The 30-day morbidity was 17.8% including 3 ischemic strokes, 2 hemorrhagic strokes, 1 gastrointestinal bleed, 1 myocardial infarction, and 1 new-onset cranial neuropathy.There was 1 ischemic stroke with lasting morbidity, making the 30-day rate of major stroke or death 2.2%.At the last follow-up, cranial nerve deficits resolved in 19 patients, improved in 11, were unchanged in 14, and worsened in 1.Brown, b.L.Et al.(2016).The fate of cranial neuropathy after flow diversion for carotid aneurysms.Journal of neurosurgery, 124(4), 1107-1113.Doi:10.3171/2015.4.Jns142790.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 5762381
• MDR Text Key: 48569312
• Report Number: 2029214-2016-00481
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other